Talent.com
Associate Director, Regulatory Affairs - Oncology

Associate Director, Regulatory Affairs - Oncology

Gilead Sciences, Inc.Foster City, CA, United States
24 days ago
Job type
  • Full-time
Job description

Associate Director, Regulatory Affairs - Oncology

Job Description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working to develop therapies that help improve lives and ensure access to these therapies globally. Our mission requires collaboration, determination and a relentless drive to make a difference.

We are seeking a capable regulatory affairs leader to contribute to the discovery and development of life-changing scientific innovations. As a people leader at Gilead and Kite, you will help create an inclusive culture where every employee feels developed and empowered to fulfil their aspirations.

Job Description

Specific Education & Experience Requirements :

  • 10+ years of experience in Regulatory Affairs or other relevant industry experience.
  • Degree in a scientific field is preferred.

Specific Job Responsibilities :

  • Prepare and / or oversee technically complex regulatory submissions requiring extensive cross-functional interaction for investigational and commercial products in assigned territories, in line with ICH, regional requirements and company policies.
  • May direct others in accomplishing Corporate Objectives.
  • Submit complex regulatory documents including safety reports, amendments, supplements and license renewals for clinical trial applications and marketing authorizations (INDs / CTAs and NDAs / MAAs) in assigned territories.
  • Prepare Company Core Data Sheets (CCDS) for assigned products and contribute to regulatory review of draft Core Safety Information (CCSI), ensuring updates are implemented.
  • Ensure product packaging and related information are updated and maintained per product license.
  • Provide strategic regulatory advice as appropriate and maintain up-to-date knowledge of regulatory requirements; communicate changes to project teams and senior management in a timely manner.
  • Initiate local and global process improvements with significant impact for Regulatory Affairs or other departments.
  • Plan, schedule and manage own activities and, if applicable, the activities of direct reports.
  • Demonstrate excellent verbal and written communication and interpersonal skills; possess in-depth knowledge of ICH and regional regulatory requirements and current global / regional trends.
  • Develop and implement regulatory strategy and manage complex negotiations with Regulatory Authorities.
  • Lead or participate in cross-functional teams for major regulatory changes; may lead a small team in submission preparation and license maintenance.
  • Work with minimal direction from senior Regulatory Affairs professionals and serve as a knowledgeable resource for Regulatory Advice in other departments.
  • Act as primary Company contact with Regulatory Authorities; direct regulatory experience in assigned territories is required and experience representing Regulatory Affairs on submission teams is mandatory (Project Teams desirable).
  • Salary Range

    The salary range for this position is :

  • Bay Area : $182,070.00 - $235,620.00
  • Other US Locations : $165,495.00 - $214,170.00
  • Additional Information

    Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may be eligible for discretionary bonuses, stock-based incentives, paid time off, and a comprehensive benefits package (medical, dental, vision, life insurance, etc.). Benefits information is available at the Gilead careers site.

    Equal Employment Opportunity

    Gilead Sciences Inc. is an equal opportunity employer. Employment decisions are made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity or expression, veteran status, or other protected characteristics as required by law.

    Application Note

    For current Gilead employees and contractors, please apply via the Internal Career Opportunities portal in Workday. Requisition ID : R0047092. Full-Time. Job Level : Associate Director.

    #J-18808-Ljbffr

    Create a job alert for this search

    Associate Regulatory • Foster City, CA, United States

    Related jobs
    • Promoted
    Regulatory Affairs Associate Director #4360

    Regulatory Affairs Associate Director #4360

    GrailMenlo Park, CA, US
    Full-time
    Regulatory Affairs Associate Director #4360.Our mission is to detect cancer early, when it can be cured.We are working to change the trajectory of cancer mortality and bring stakeholders together t...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, CMC Regulatory

    Associate Director, CMC Regulatory

    Revolution MedicinesRedwood City, CA, United States
    Full-time
    Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline com...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Clinical Operations

    Associate Director, Clinical Operations

    Corcept TherapeuticsRedwood City, CA, US
    Full-time
    Associate Director, Clinical Operations.Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (...Show moreLast updated: 8 days ago
    • Promoted
    Associate Director / Director, Regulatory Affairs

    Associate Director / Director, Regulatory Affairs

    Dren Bio, Inc.Foster City, CA, United States
    Full-time
    Associate Director / Director, Regulatory Affairs.Dren Bio is a privately held, clinical-stage biopharmaceutical company pioneering the discovery and development of first-in-class antibody therapeut...Show moreLast updated: 12 days ago
    • Promoted
    Regulatory Affairs Associate Director, IVD #4360

    Regulatory Affairs Associate Director, IVD #4360

    GRAILMenlo Park, CA, United States
    Full-time
    Our mission is to detect cancer early, when it can be cured.We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective tech...Show moreLast updated: 30+ days ago
    • Promoted
    Director / Senior Director, Regulatory Affairs (Clinical & CMC)

    Director / Senior Director, Regulatory Affairs (Clinical & CMC)

    Valid8 Financial, Inc.San Francisco, CA, United States
    Full-time
    Director / Senior Director, Regulatory Affairs (Clinical & CMC).Director / Senior Director, Regulatory Affairs.This individual will oversee both Clinical and CMC regulatory functions, providing strat...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Clinical Contracts & Oncology Outsourcing Director

    Associate Clinical Contracts & Oncology Outsourcing Director

    ExelixisAlameda, CA, US
    Full-time
    Associate Outsourcing Director.The Associate Outsourcing Director will be a Category Manager within the Strategic Sourcing and Procurement (SS&P) department based on the category(ies) they are assi...Show moreLast updated: 20 days ago
    • Promoted
    Associate Director, Clinical Operations

    Associate Director, Clinical Operations

    Revolution MedicinesRedwood City, CA, US
    Full-time
    Associate Director, Clinical Operations.Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicte...Show moreLast updated: 30+ days ago
    • Promoted
    Corporate Associate (Healthcare and Life Sciences Privacy) - Silicon Valley

    Corporate Associate (Healthcare and Life Sciences Privacy) - Silicon Valley

    Direct CounselSan Jose, CA, US
    Full-time
    Associate – Healthcare & Life Sciences Privacy (Digital Health).San Francisco or Silicon Valley.Healthcare and Life Sciences Regulatory. Direct Counsel is representing an Am Law 100 firm.H...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Regulatory Affairs - Oncology

    Associate Director, Regulatory Affairs - Oncology

    GileadSan Mateo, CA, US
    Full-time
    At Gilead, we're creating a healthier world for all people.For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapie...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Regulatory Affairs

    Associate Director, Regulatory Affairs

    Maze TherapeuticsSan Francisco, CA, US
    Full-time
    Join Maze Therapeutics as an Associate Director, Regulatory Affairs, where you will play a critical role in advancing our clinical-stage programs by providing regulatory expertise and executional l...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Clinical Quality

    Associate Director, Clinical Quality

    Revolution MedicinesRedwood City, CA, US
    Full-time
    Associate Director, Clinical Quality Assurance.Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Regulatory Affairs

    Associate Director, Regulatory Affairs

    Revolution MedicinesRedwood City, CA, United States
    Full-time
    Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline com...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director or Director of Regulatory Affairs and Quality Assurance6425 Christie Avenue, Emeryville, CA

    Associate Director or Director of Regulatory Affairs and Quality Assurance6425 Christie Avenue, Emeryville, CA

    DermBiontEmeryville, CA, US
    Full-time
    Associate Director Or Director Of Regulatory Affairs And Quality Assurance.DermBiont is a clinical stage biotech company with multiple active INDs enabling multiple Phase 2 clinical trials.Assuming...Show moreLast updated: 30+ days ago
    • Promoted
    Director, Regulatory Affairs

    Director, Regulatory Affairs

    Revolution MedicinesSan Francisco, CA, United States
    Full-time
    Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline com...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Director, RA Global Regulatory Strategy

    Director, RA Global Regulatory Strategy

    AllerganSan Francisco, CA, United States
    Full-time
    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable i...Show moreLast updated: 10 hours ago
    • Promoted
    Director of Regulatory Affairs

    Director of Regulatory Affairs

    Connect Life ScienceSan Jose, CA, US
    Full-time
    Senior Director of Regulatory Affairs.Hybrid working - some travel to Bay Area.Medical Devices – Class III.Competitive compensation + strong benefits. Director of Regulatory Affairs.US and a p...Show moreLast updated: 4 days ago
    • Promoted
    Associate Director Clinical Pharmacology – San Francisco Biotech

    Associate Director Clinical Pharmacology – San Francisco Biotech

    TANNER & ASSOC INCSan Francisco, CA, United States
    Full-time
    Associate Director Clinical Pharmacology – San Francisco Biotech.New Position : Associate Director Clinical Pharmacology – San Francisco Biotech. The Associate Director role will have a broad range o...Show moreLast updated: 3 days ago
    • Promoted
    Associate Director, Clinical Operations- Biomarker & Bioanalytical Operations

    Associate Director, Clinical Operations- Biomarker & Bioanalytical Operations

    GileadSan Mateo, CA, US
    Full-time
    At Gilead, we're creating a healthier world for all people.For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapie...Show moreLast updated: 9 days ago
    • Promoted
    Associate Director, Regulatory Affairs - Oncology

    Associate Director, Regulatory Affairs - Oncology

    Gilead Sciences, Inc.Foster City, CA, United States
    Full-time
    Associate Director, Regulatory Affairs - Oncology.At Gilead, we’re creating a healthier world for all people.For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 an...Show moreLast updated: 24 days ago